Regulatory Affairs Specialist

1 day ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 25,00,000 - ₹ 40,00,000

Job Title: Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will involve working closely with international regulatory teams to understand their evolving business needs and requirements.

The successful candidate will have excellent communication skills, be able to navigate complex regulatory environments, and possess a strong understanding of medical devices regulations in India.

Key Responsibilities:

  • Assist in understanding the Indian Medical Device Regulations (MDR) and its impact on business operations.
  • Serve as a consultant, advisor, and guide to the international regulatory team, providing solutions-oriented support.
  • Engage with regulatory authorities in India, such as CDSCO, to clarify regulatory requirements and ensure compliance.
  • Evaluate and recommend technology platforms to manage licenses and process flows for multiple operating companies within the group.
  • Minimize risk to business disruption from regulation and stay up-to-date with changing regulatory environments.
  • Utilize membership with MTAI effectively for advocacy and position the company's viewpoint when required.

Critical Success Factors:

  • Executional rigor, due diligence regarding documentation, and process-oriented approach for day-to-day MDR licensing requirements.
  • Understand varying needs across diverse stakeholders, particularly different types of medical devices.
  • Effective communication with all stakeholders and commercial acumen when recommending solutions.
  • Deep understanding of evolving Indian MDR regulations.

Qualifications:

  • Degree in Regulatory Management or related field.

Experience:

  • Minimum 1-3 years of relevant experience in regulatory affairs.
  • Core end-to-end experience in Indian MDR regulations.
  • Experience with regulatory license platforms and exposure to related operational issues.
  • Exposure to European MDR and FDA regulations an advantage.

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